Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention

Stroke Clinical Trial

— EMT-OCSP  

Official title:

Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention(EMT-OCSP): a Pragmatic,Multi-centre, Observer-blinded,12-month Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450888
• Other study ID #: 610041
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 22, 2022

Study information

• Verified date: March 2022
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of Message framing and Time discounting on heath communication for Optimum Cardiovascular disease and Stroke Prevention（EMT-OCSP）is a pragmatic, 2 × 2 factorial, randomized, controlled, observer blinded, multicenter trial with four parallel groups. It aims to determine if risk and intervention communication strategy（gain-framed versus loss-frame, long-term context versus short-term context and the potential interaction）have different effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk reduction）for subjects with at least one moldable risk factor for CVD.

Description:

Scientific title Effects of Message framing and Time discounting on health communication for Optimum Cardiovascular disease and Stroke Prevention(EMT-OCSP): a pragmatic randomised controlled study

Principal Investigator Li He

Study period 2020-07-01-2022-01-21

Hypotheses and aims When communicating cardiovascular disease（CVD）risk to individuals, different presentation of information carries its own connotations and biases. The one or the other pattern of the presentation may affect individuals' decision making.This study aims to determine if risk and intervention communication strategy（gain-framed versus loss-frame, long-term context versus short-term context and the potential interaction）have different effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk reduction）for subjects with at least one moldable risk factor for CVD. We aim to provide evidence for practitioners regarding messaging strategies that improve communication effectiveness and further reduce the risk of CVD events in the population, as well as to develop more effective communication strategies for groups of people with different characteristics to maximise patient adherence to lifestyle modifications and medical treatment.

Primary outcome Ten-year CVD risk, lifetime CVD risk and CVD-free life expectancy after 1 year according to the LIFE-CVD model.

Secondary outcomes CVD risk factors [blood pressure(BP) and serum cholesterol, low-density lipoprotein (LDL), non-high-density lipoprotein (HDL), triglycerides and fasting glucose levels],lifestyle factors (physical activity, tobacco use, alcohol use and eating habits), pharmacological treatments for hypertension, dyslipidaemia and diabetes, and anti-thrombotic drug prescriptions after 1 year.

Study design The EMT-OCSP trial is designed as a pragmatic, 2 × 2 factorial, randomized, controlled, observer blinded, multicenter trial with four parallel groups. Randomization will be performed as block randomization with a 1:1:1:1 allocation.

Study population and sample size Subjects with at least one moldable risk factor for CVD. The sample size calculations revealed that the enrolment of 15,000 participants would be sufficient, allowing for a 20% drop-out rate.

Follow-up period One year

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13114
• Est. completion date: January 22, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• aged 45-80 years,

• personally own and use a smartphone (Apple or Android platform) with Internet access,

• and have at least one of the following CVD risk factors: history of CVD at age < 60 years in a first-degree relative, smoking, diabetes, hypertension, and low-density lipoprotein (LDL)cholesterol = 4.5 mmol/L.

Exclusion Criteria:

• participants with histories of CVD, heart failure, or chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2);

• those with terminal malignancy at baseline;

• those with severe psychological or mental disorders

• violation of the study protocol and participation in another clinical study during follow-up

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Primary Prevention
• Stroke

Intervention

Other:
• The strategic use of messages in risk communication
The interventions in the EMT-OCSP study are strategic health messages delivered (gain-framed vs.loss-framed and long-term vs.short-term contexts) to individuals based on their calculated CVD-free life expectancy and potential interventional benefits.

Locations

Country	Name	City	State
China	Health center of Sipo town	Yibin	Sichuan

Sponsors (5)

Lead Sponsor	Collaborator
West China Hospital	Beijing Tiantan Hospital, Centers for Disease Control and Prevention, China, China Stroke Databank Center, First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-year CVD risk		At the 1-year follow-up
Primary	Lifetime CVD risk		At the 1-year follow-up
Primary	CVD-free life expectancy		At the 1-year follow-up
Secondary	Changes in systolic and diastolic blood pressure		At the 1-year follow-up
Secondary	Changes in serum cholesterol level		At the 1-year follow-up
Secondary	Changes in serum LDL level		At the 1-year follow-up
Secondary	Changes in serum non-HDL level		At the 1-year follow-up
Secondary	Changes in serum triglycerides level		At the 1-year follow-up
Secondary	Changes in fasting glucose level		At the 1-year follow-up
Secondary	Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)		At the 1-year follow-up
Secondary	Changes in tobacco use	Tobacco use status (current, former, never) in the records at visits	At the 1-year follow-up
Secondary	Changes in alcohol use (AUDIT questionnaire)		At the 1-year follow-up
Secondary	Changes in dietary habits (food frequency questionnaire)		At the 1-year follow-up
Secondary	Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user)	A persistent medication user is defined as a participant who has purchased the drug at least once during each 3-month interval during our study.	At the 1-year follow-up
Secondary	Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user)		At the 1-year follow-up
Secondary	Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user)		At the 1-year follow-up
Secondary	Changes adherence to anti-thrombotic therapy (proportion of persistent medication user)		At the 1-year follow-up